Pharma Focus Asia

CStone and 3SBio Establish Exclusive Licensing Agreement and Strategic Partnership for Nofazinlimab (Anti-PD-1 Antibody) in Mainland China

Thursday, November 02, 2023

CStone Pharmaceuticals, a leading biopharmaceutical company specializing in innovative immuno-oncology therapies and precision medicines, has announced a strategic partnership and exclusive licensing agreement with Shenyang Sunshine Pharmaceutical Co., Ltd., a subsidiary of 3SBio Inc., regarding an anti-PD-1 antibody called nofazinlimab within mainland China.

According to the terms of the partnership, 3SBio will provide an upfront payment of 60 million RMB to CStone, along with an additional 100 million RMB designated for development and registration milestones, along with future payments tied to sales milestones and tiered sales royalties. In return, 3SBio will acquire exclusive rights for the development, registration, manufacturing, and commercialization of nofazinlimab within mainland China. CStone will maintain the rights to nofazinlimab outside of mainland China and is actively seeking partners for further development.

CStone, expressed his enthusiasm about the collaboration with 3SBio, highlighting nofazinlimab's potential as the first anti-PD-(L)1 antibody in combination with lenvatinib for advanced Hepatocellular Carcinoma (HCC) in the first-line setting. This partnership is expected to broaden the potential indications for nofazinlimab and maximize its clinical value in the Chinese market.

3SBio Inc., welcomed the licensing agreement, emphasizing 3SBio's experience in antibody research and development, production capabilities, and strong oncology commercialization team. He believes that nofazinlimab will complement 3SBio's existing pipeline and contribute to the development of effective and affordable cancer treatments.

Nofazinlimab, an anti-PD-1 antibody developed by CStone, is currently undergoing a Phase 3 study to evaluate its efficacy in combination with lenvatinib for advanced HCC patients. The topline results are expected in the first quarter of 2024, which will support new drug applications in China, the United States, and Europe.

Preliminary data from early-stage trials show that nofazinlimab has demonstrated promise in multiple tumor types. Additionally, data from a Phase Ib study in combination with lenvatinib for advanced HCC patients in China displayed favorable results, including an objective response rate of 45% and a median progression-free survival of 10.4 months.

Nofazinlimab is a humanized monoclonal antibody targeting PD-1, and it has received Orphan Drug Designation from the U.S. FDA for the treatment of HCC.

Hepatocellular carcinoma (HCC) is a common form of liver cancer and a significant global health concern. It is responsible for a substantial number of cancer-related deaths and typically presents at an advanced stage, making systemic therapies essential for treatment. The prognosis for advanced-stage HCC is generally poor, and new treatment options like nofazinlimab are eagerly anticipated.



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